The art relating to penile prosthetic devices is well established, with representative examples of the basic structures of and improvements to such devices being shown in U.S. Pat. No. 5,167,611 to Cowan, U.S. Pat. No. 5,250,020 to Bley, and U.S. Pat. No. 5,062,417 to Cowen. Each of those patents is owned by the assignee of the present application, and suggest various embodiments of a penile prosthesis which have proven operational and commercially suitable.
These examples certainly do not exhaust the structural configurations and functional variations that may be adopted for such a prosthesis, and it is recognized that a wide array of similar products have been developed and are well known to those skilled in the art--emanating both from the assignee of this application and many other individuals and companies.
For purposes of describing the improvement of this invention, it is sufficient to focus on the basic structural components of these representative devices. The common elements include a pair of elongated cylindrical chambers that are implanted within the corpora cavernosa of a patient, and which may be inflated using a biologically compatible fluid to achieve an erection in the patient. The device further includes a reservoir for that fluid, and a pump for transferring fluid from the reservoir to the chambers under pressure. To facilitate operation of the prosthesis, an array of valves must be utilized in combination with the pump to control the flow of the fluid. When the reservoir is located at a remote position relative to the chambers, the reservoir and chambers must be operationally interconnected using tubing or a similar conduit for the fluid. In such devices, it has proven advantageous to locate the pump within the scrotum of the patient, and the reservoir may optionally be located at a remote position such as behind the pelvic wail or combined unitarily with the pump in a Resipump.TM. design.
One problem associated with such prostheses is the tendency for the tubing forming the fluid conduits to leak or completely separate from the valve block, reservoir, or cylinders. Because the pump and valve block are disposed within the scrotum of the patient where they are subject to more unrestricted freedom of movement as well as intentional manipulation by the patient during operation, the connections between the tubing and valve block appear subject to the greatest potential for damage or separation.
The tubing may remain intact for relatively long periods of time (up to the useful life of the prosthesis), may gradually form a relatively small leak due to a fracture or tear at or near the junction of with another component such as the valve block, or may separate completely from a component without advance warning. The compromise of the closed system may occur in the tubing, at the junction between the tubing and a component, or within the tubing-to-component junction itself. These conditions are probably in an adhered, seated, or molded junction. While forming the tubing or conduits unitarily with the other components will reduce the frequency of leaks and separations compared to devices utilizing bonded connections, it can also unduly increase the overall complexity and cost of manufacturing the prosthesis to unacceptable levels.